Photodynamic articular joint implants and methods of use

ABSTRACT

Photodynamic devices for replacement of an articular head of a bone are provided. In an embodiment, a photodynamic device includes a photodynamic support member and an articular member attachable, either fixedly or removably, to the photodynamic support member and having a bearing surface. In an embodiment, the articular member includes a recess designed to receive the photodynamic support member. In an embodiment, the photodynamic support member includes an opening into which a shaft of the articular member can be inserted to attach the articular member to the photodynamic support member.

RELATED APPLICATIONS

This application is a continuation patent application of U.S.application Ser. No. 16/382,642, filed on Apr. 12, 2019, now U.S. patentSer. No. 11/141,207, which is a continuation patent application of U.S.application Ser. No. 14/843,286, filed on Sep. 2, 2015, now U.S. Pat.No. 10,292,823, which is a continuation patent application of U.S.application Ser. No. 13/553,450, filed on Jul. 19, 2012, now U.S. Pat.No. 9,144,442, which claims the benefit of and priority to U.S.Provisional Patent Application No. 61/509,459, filed on Jul. 19, 2011,U.S. Provisional Patent Application No. 61/509,314, filed on Jul. 19,2011, and U.S. Provisional Patent Application No. 61/509,391, filed onJul. 19, 2011, these applications are hereby incorporated herein byreference in their entireties.

FIELD

The embodiments disclosed herein relate to bone implants, and moreparticularly to photodynamic devices for replacement of an articularhead of a bone.

BACKGROUND

Bones form the skeleton of the body and allow the body to be supportedagainst gravity and to move and function in the world. Bone fracturescan occur, for example, from an outside force or from a controlledsurgical cut (an osteotomy). A fracture's alignment is described as towhether the fracture fragments are displaced or in their normal anatomicposition. In some instances, surgery may be required to re-align andstabilize the fractured bone. But proper positioning of a bone,particularly in a joint, is difficult to achieve. It would be desirableto have an improved device or method for repairing and positioning afractured or weakened bone.

SUMMARY

Devices for replacement of an articular head of a bone are provided. Inone aspect, there is provided an articular bone repair device includinga support member and an articular member. The articular member has anarticular part, a bearing surface disposed on the articular part, and anattachment part configured to complementarily engage the support member.The support member is sufficiently designed to reside within a cavity ofa bone to anchor the articular member inside the cavity.

In an embodiment, the articular member is fixedly attached to thesupport member. In an embodiment, the articular member is removablyattached to the support member. In an embodiment, the device alsoincludes a recess in the articular member wherein the recess is designedto receive the support member. In an embodiment, the articular memberhas a shaft and the support member includes an opening into which theshaft of the articular member can be inserted to attach the articularmember to the support member. In an embodiment, the articular member hasat least a portion that is cylindrical, tubular, rounded or ball-shaped.In an embodiment, the bearing surface is configured to enter into anarticular engagement with an articular head of a bone opposing the boneto be repaired. In an embodiment, the support member is curable and/orphotodynamic.

In an aspect, a joint repair device includes: a first bone repair devicehaving a first support member attached to a first articular memberhaving a first bearing surface; and a second bone repair device having asecond photodynamic support member attached to a second articular memberhaving a second bearing surface complementary to and engaged with thefirst bearing surface.

In an embodiment, the first articular device and the second articulardevice are used in conjunction with a complementary surface other thananother bone repair device. In an embodiment, the complementary surfaceis an acetabular cup, a liner, or both. In an embodiment, the firstbearing surface is able to articulate with respect to the second bearingsurface. In an embodiment, the second bearing surface is able toarticulate with respect to first bearing surface. In an embodiment, thefirst support device is curable and/or photodynamic. In an embodiment,the second support device is curable and/or photodynamic.

In an aspect, a system for restructuring or stabilizing a fractured orweakened head of a bone includes: a delivery catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, the delivery catheter having an inner void forpassing at least one light sensitive liquid therethrough, and an innerlumen; an expandable member releasably engaging the distal end of thedelivery catheter; an articular member attached to the expandable memberand having a bearing surface; and a light conducting fiber sized to passthrough the inner lumen of the delivery catheter and into the expandablemember. The expandable member is configured to receive the articularmember. The expandable member moves from a deflated state to an inflatedstate when the at least one light sensitive liquid is passed to theexpandable member. The expandable member is sufficiently designed to beat least partially placed into a space within the head of the bone. Whenthe light conducting fiber is in the expandable member, the lightconducting fiber is able to disperse light energy to initiate hardeningof the at least one light sensitive liquid within the expandable memberto form a photodynamic implant. In an embodiment, the articular memberhas a shaft and the expandable member has an opening configured toreceive the shaft of the articular member.

In an aspect, a method for repairing a fractured or weakened articularhead of a bone includes: removing the fractured or weakened head fromthe bone; placing an expandable member removably attached to a distalend of a delivery catheter at least partially into an intramedullarycavity of the bone; attaching an articular member having a bearingsurface to the expandable member, wherein the expandable member isconfigured to receive the expandable member; infusing a light sensitiveliquid into the expandable member through an inner lumen of the deliverycatheter; activating a light conducting fiber to cure the lightsensitive liquid inside the expandable member; and separating theexpandable member and the articular member from the delivery catheter.

In an embodiment, the method also includes inserting the lightconducting fiber into the expandable member. In an embodiment, themethod further includes removing the light conducting fiber from theexpandable member after curing the light sensitive liquid inside theexpandable member. In an embodiment, the method includes inserting ashaft of the articular member into an opening in the expandable memberto attach the articular member to the expandable member.

In an aspect, a kit for repairing or stabilizing a fractured or weakenedhead of a bone includes: a light conducting fiber; at least one lightsensitive liquid; a delivery catheter having an elongated shaft with aproximal end, a distal end, and a longitudinal axis therebetween; anexpandable member releasably engaging the distal end of the deliverycatheter, wherein the delivery catheter has an inner void for passingthe at least one light sensitive liquid into the expandable member, andan inner lumen for passing the light conducting fiber into theexpandable member; and an articular member configured to be attached tothe expandable member and having a bearing surface.

In an embodiment, the kit includes a plurality of expandable membershaving different sizes or shapes. In an embodiment, the kit includes aplurality of articular members having different sizes or shapes. In anembodiment, the kit includes a light source.

Photodynamic devices for replacement of an articular head of a bone areprovided. In one aspect, there is provided an articular photodynamicdevice that includes a photodynamic support member and an articularmember attachable, either fixedly or removably, to the photodynamicsupport member and having a bearing surface. In an embodiment, thearticular member includes a recess designed to receive the photodynamicsupport member. In an embodiment, the photodynamic support memberincludes an opening into which a shaft of the articular member can beinserted to attach the articular member to the photodynamic supportmember.

In an aspect, there is provided a photodynamic joint repair device thatincludes a first photodynamic bone repair device having a first bearingsurface and a second photodynamic bone repair device having a secondbearing surface complementary to the first bearing surface. Each of thefirst and second photodynamic bone repair devices include a photodynamicsupport member and a articular member having a bearing surface. In anembodiment, an articular photodynamic devices of the present disclosureis used in conjunction with a complementary surface other than anotherphotodynamic bone repair device of the present disclosure, such as forexample, an existing acetabular cup and/or liner.

In an aspect, there is provided a device for restructuring orstabilizing a fractured or weakened head of a bone includes a deliverycatheter having an elongated shaft with a proximal end, a distal end,and a longitudinal axis therebetween, the delivery catheter having aninner void for passing at least one light sensitive liquid, and an innerlumen; a expandable member releasably engaging the distal end of thedelivery catheter, the expandable member moving from a deflated state toan inflated state when the at least one light sensitive liquid is passedto the expandable member; wherein the expandable member is sufficientlydesigned to be at least partially placed into a space within a head of abone, and a light conducting fiber sized to pass through the inner lumenof the delivery catheter and into the expandable member, wherein, whenthe light conducting fiber is in the expandable member, the lightconducting fiber is able to disperse the light energy to initiatehardening of the at least one light sensitive liquid within theexpandable member to form a photodynamic implant.

In an aspect, there is provided a method for repairing a fractured orweakened articular head of a bone that includes removing the fracturedor weakened head of the bone from the bone, placing a expandable memberremovably attached to a distal end of a delivery catheter at leastpartially into an intramedullary cavity of the bone, attaching anarticular member having a bearing surface to the expandable member,infusing a light sensitive liquid into the expandable member through aninner lumen of the delivery catheter, inserting a light conducting fiberinto the expandable member through an inner void of the deliverycatheter, and activating the light conducting fiber to cure the lightsensitive liquid inside the expandable member and separating theexpandable member from the delivery catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments.

FIG. 1 shows a schematic illustration of an embodiment of an articularphotodynamic bone repair device of the present disclosure, including aphotodynamic support member and an articular member.

FIG. 2 shows a schematic illustration of an embodiment of a bone implantsystem of the present disclosure. The system includes a light source, alight pipe, an attachment system, a light-conducting fiber, alight-sensitive liquid, a delivery catheter and a expandable member.

FIG. 3A and FIG. 3B show close-up cross-sectional views of the regioncircled in FIG. 2 . FIG. 3A shows a cross-sectional view of a distal endof the delivery catheter and the expandable member prior to the devicebeing infused with light-sensitive liquid. FIG. 3B shows across-sectional view of the distal end of the delivery catheter and theexpandable member after the device has been infused with light-sensitiveliquid and light energy from the light-conducting fiber is introducedinto the delivery catheter and inner lumen of the expandable member tocure the light-sensitive liquid.

FIGS. 4A-4G illustrate an embodiment of an articular photodynamic deviceof the present disclosure in which a photodynamic support member isinserted into a recess in an articular member.

FIG. 5A and FIG. 5B illustrate an embodiment of an articularphotodynamic device of the present disclosure in which a photodynamicsupport member includes a centerline opening for receiving a shaft of anarticular member.

FIG. 6 illustrates an embodiment of a joint repair device of the presentdisclosure.

FIG. 7 illustrates another embodiment of a joint repair device of thepresent disclosure.

FIG. 8A, FIG. 8B, and FIG. 8C show an embodiment of method steps forusing an articular photodynamic device of the present disclosure.

FIG. 8D, FIG. 8E, and FIG. 8F show cross-sectional side views ofembodiments of the coupling of the articular member and the expandablemember in a radial bone.

FIG. 8G shows a cross-sectional side view of an embodiment of anarticular photodynamic device.

FIG. 9A and FIG. 9B show another embodiment of method steps for using anarticular photodynamic device of the present disclosure.

FIG. 10A shows a schematic illustration of an embodiment of an articularphotodynamic device of the present disclosure used to replace a proximalhead of a humerus.

FIG. 10B shows a schematic illustration of an embodiment of an articularphotodynamic device of the present disclosure used to repair a proximalhead of a humerus.

While the above-identified drawings set forth presently disclosedembodiments, other embodiments are also contemplated, as noted in thediscussion. This disclosure presents illustrative embodiments by way ofrepresentation and not limitation. Numerous other modifications andembodiments can be devised by those skilled in the art which fall withinthe scope and spirit of the principles of the presently disclosedembodiments.

DETAILED DESCRIPTION

Medical devices and methods for replacing an articular head of a boneare provided. Medical devices and methods for repairing an articularjoint are also provided. The term “bone” as used herein refer to anelongated bone having rounded ends, or heads, at its joint with anadjacent bone. The bones include, without limitation, the femurs,tibias, and fibulas of the legs, the humeri, radii, and ulnas of thearms, metacarpals and metatarsals of the hands and feet, the phalangesof the fingers and toes, the spanning or joining of the wrist, themandible, pelvis, and ribs, and spine. The devices of the presentdisclosure are suitable for repairing various joints, including, but notlimited to, ankle joints, finger joints, toe joints, knee joints, hipjoints, wrist joint, elbow joints, mandibular joint, and shoulderjoints. In an embodiment, the device is used in a wrist arthrodesisprocedure. In an embodiment, an articular joint implant of the presentdisclosure is used to treat a fractured or weakened bone.

As used herein, the terms “fracture” or “fractured bone” refer to apartial or complete break in the continuity of a bone. The fracture canoccur, for example, from an outside force or from a controlled surgicalcut (osteotomy). The presently disclosed embodiments can be used totreat any type of bone fracture, including, but not limited to, adisplaced fracture, a non-displaced fracture, an open fracture, a closedfracture, a hairline fracture, a compound fracture, a simple fracture, amulti-fragment fracture, a comminuted fracture, an avulsion fracture, abuckle fracture, a compacted fracture, a stress fracture, a compressionfracture, spiral fracture, butterfly fracture, other fractures asdescribed by AO Foundation coding, multiple fractures in a bone, andother types of fractures.

As used herein, the term “weakened bone” refers to a bone with apropensity toward a fracture due to a decreased strength or stabilitydue to a disease or trauma. Some bone diseases that weaken the bonesinclude, but are not limited to, osteoporosis, achondroplasia, bonecancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, leggcalve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis,osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bonesare more susceptible to fracture, and treatment to prevent bonefractures may be desirable.

In an embodiment, the devices are used as an interim spacer in a jointsuch as a hip. For example, the device is used when an implant needs tobe removed, an infection subsides, and then an implant is reinserted.Thus, in an embodiment, the device is used to hold the bone (without animplant) in proper spacial alignment, while not being used as a bearingsurface.

FIG. 1 illustrates an embodiment of an articular photodynamic bonerepair device 100 of the present disclosure for replacing or repairingan articular head of a bone 112. The photodynamic bone repair device 100includes a photodynamic support member 102 and an articular member 104attachable, either fixedly or removably, to the photodynamic supportmember 102 and having a bearing surface 106.

In an embodiment, the photodynamic support member 102 is sufficientlydesigned to reside within an intramedullary cavity 108 of the bone 112in order to anchor the articular member 104 inside the intramedullarycavity 108. In an embodiment, the photodynamic support member 102provides longitudinal and rotational stabilization for the articularmember 104. In an embodiment, the photodynamic support member 102 actsto center the articular member 104 inside the intramedullary cavity 108.In an embodiment, the photodynamic support member 102 acts to adjust theangle of the articular member 104 relative to the longitudinal axis ofthe bone 112. In an embodiment, the photodynamic support member 102enables the user to adjust the length of the repaired bone to avoidforeshortening of the bone.

The articular member 104 is sufficiently designed to approximate thedimensions and size of an articular head of a bone being repaired. Thearticular member 104 has any suitable size and shape. In an embodiment,at least a portion of the articular member 104 is roughly cylindrical ortubular in shape. In an embodiment, at least a portion of the articularmember 104 is rounded or ball-shaped.

The articular member 104 can be construed of any biologically acceptablematerial, including, without limitation, a ceramic, plastic, metal oralloy. Suitable metals and metal alloys include, but are not limited to,Nb, Zr, Ti, Ta, Co, V, Cr, Al, alloys thereof, stainless steel, cobaltchrome and combinations thereof. Suitable ceramic materials include, butare not limited to, alumina, zirconia, chromium carbide, chromiumnitride, silicon carbide, silicon nitride, titanium carbide, zirconiumcarbide, zirconium nitride, tantalum carbide, tungsten carbide, and anycombination thereof.

The articular member 104 includes an attachment part 114 and anarticular part 116. The attachment part 114 is the part of the articularmember 116 where the photodynamic support member 102 attaches to thearticular member 104. The articular part 116 is the part of thearticular member 116 upon which the bearing surface 106 is disposed.

In an embodiment, the bearing surface 106 is configured to approximatethe dimensions, size and shape of the bearing surface of an articularhead of a bone being repaired. As shown in FIG. 1 , the bearing surface106 is sized and shaped to enter into an articular engagement with anarticular head 118 of an opposing bone 122, that is, the bone with whichthe bone 112 being repaired engages to form an articular joint 124. Inan embodiment, the bearing surface 106 is concave. In an embodiment, thebearing surface 106 is flat. In an embodiment, the bearing surface 106is convex. In an embodiment, the shape of the bearing surface variesalong the bearing surface. In an embodiment, the bearing surface 106 isan integral part of the articular member 104. In an embodiment, thebearing surface 106 is a separate part from the articular member 106 andcan be attached by any suitable means to the articular part 116 of thearticular member 104 either fixedly or removably. For example, thebearing surface can be mounted on the top of an implant (i.e., the head)or affixed to the tip of the implant so that as the curing processoccurs, the implant may grab, bond, or attach itself to the bearingsurface, such as a metallic stem. In an embodiment, the bearing surfacehas a screw hole or a compression fitting that is used to attach thearticular part of the bearing surface to that of the implant. In anembodiment, the bearing surface 106 is sufficiently designed towithstand the loads and wear on the bearing surface generated by normalactivities of the patient post implantation. In an embodiment, thebearing surface 106 is sufficiently designed, i.e., provided with size,shape and material, to ensure low friction between the bearing surface106 and the articular head 118. The bearing surface 106 may be made ofany suitable metallic material, ceramic material, or low-frictionplastic, such as polyethylene. The bearing surface 106 can also includea coating designed to decrease friction between the bearing surface ofthe articular member 10 and the opposing bone.

The photodynamic support member 102 is formed in any suitable manner.For example, as is described in detail below, the photodynamic supportmember 102 is formed by filling an expandable member 170, such as aballoon, with a photodynamic (light-curable) liquid 165 and exposing thephotodynamic (light-curable) liquid 165 to an appropriate frequency oflight and intensity to cure the photodynamic liquid 165 inside theexpandable member 170 to form a rigid structure within a cavity in abone, such as the intramedullary cavity 108 (see FIGS. 3A and 3B).

FIG. 2 in conjunction with FIG. 3A and FIG. 3B show schematicillustrations of an embodiment of a bone implant system 200 of thepresent disclosure for formation and implantation of the photodynamicsupport member 102. System 200 includes a light source 110, a light pipe120, an attachment system 130 and a light-conducting fiber 140. Theattachment system 130 communicates light energy from the light source110 to the light-conducting fiber 140. In an embodiment, the lightsource 110 emits frequency that corresponds to a band in the vicinity of390 nm to 770 nm, the visible spectrum. In an embodiment, the lightsource 110 emits frequency that corresponds to a band in the vicinity of410 nm to 500 nm. In an embodiment, the light source 110 emits frequencythat corresponds to a band in the vicinity of 430 nm to 450 nm. Thesystem 100 further includes a flexible delivery catheter 150 having aproximal end that includes at least two ports and a distal endterminating in an expandable member 170. In an embodiment, theexpandable member 170 is sufficiently shaped to fit within a space or agap in a fractured bone. In an embodiment, the expandable member 170 ismanufactured from a non-compliant (non-stretch/non-expansion)conformable material. In an embodiment, the expandable member 170 ismanufactured from a conformable compliant material that is limited indimensional change by embedded fibers. One or more radiopaque markers,bands or beads may be placed at various locations along the expandablemember 170 and/or the flexible delivery catheter 150 so that componentsof the system 100 may be viewed using fluoroscopy.

In some embodiments, the system includes one or more ports. In theembodiment shown in FIG. 2 , the proximal end includes two ports. One ofthe ports can accept, for example, the light-conducting fiber 140. Theother port can accept, for example, a syringe 160 housing alight-sensitive liquid 165. In an embodiment, the syringe 160 maintainsa low pressure during the infusion and aspiration of the light-sensitiveliquid 165. In an embodiment, the syringe 160 maintains a low pressureof about 10 atmospheres or less during the infusion and aspiration ofthe light-sensitive liquid 165. In an embodiment, the light-sensitiveliquid 165 is a photodynamic (light-curable) monomer. In an embodiment,the photodynamic (light-curable) monomer is exposed to an appropriatefrequency of light and intensity to cure the monomer inside theexpandable member 170 and form a rigid structure. In an embodiment, thephotodynamic (light-curable) monomer 165 is exposed to electromagneticspectrum that is visible (frequency that corresponds to a band in thevicinity of 390 nm to 770 nm). In an embodiment, the photodynamic(light-curable) monomer 165 is radiolucent, which permit x-rays to passthrough the photodynamic (light-curable) monomer 165.

As illustrated in FIG. 3A and FIG. 3B, the flexible delivery catheter150 includes an inner void 152 for passage of the light-sensitive liquid165, and an inner lumen 154 for passage of the light-conducting fiber140. In the embodiment illustrated, the inner lumen 154 and the innervoid 152 are concentric to one another. The light-sensitive liquid 165has a low viscosity or low resistance to flow, to facilitate thedelivery of the light-sensitive liquid 165 through the inner void 152.In an embodiment, the light-sensitive liquid 165 has a viscosity ofabout 1000 cP or less. In an embodiment, the light-sensitive liquid 165has a viscosity ranging from about 650 cP to about 450 cP. Theexpandable member 170 may be inflated, trial fit and adjusted as manytimes as a user wants with the light-sensitive liquid 165, up until thelight source 110 is activated, when the polymerization process isinitiated. Because the light-sensitive liquid 165 has a liquidconsistency and is viscous, the light-sensitive liquid 165 may bedelivered using low pressure delivery and high pressure delivery is notrequired, but may be used.

In an embodiment, a contrast material may be added to thelight-sensitive liquid 165 without significantly increasing theviscosity. Contrast materials include, but are not limited to, bariumsulfate, tantalum, or other contrast materials known in the art. Thelight-sensitive liquid 165 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner void 152of the flexible delivery catheter 150 up into an inner cavity 172 of theexpandable member 170 to change a thickness of the expandable member 170without changing a width or depth of the expandable member 170. In anembodiment, the light-sensitive liquid 165 is delivered under lowpressure via the syringe 160 attached to the port. The light-sensitiveliquid 165 can be aspirated and reinfused as necessary, allowing forthickness adjustments to the expandable member 170 prior to activatingthe light source 110 and converting the liquid monomer 165 into a hardpolymer.

In an embodiment, the light-sensitive liquid may be provided as a unitdose. As used herein, the term “unit dose” is intended to mean aneffective amount of light sensitive liquid adequate for a singlesession. By way of a non-limiting example, a unit dose of a lightsensitive liquid of the present disclosure for expanding the expandablemember 170 may be defined as enough light-sensitive liquid to expand theexpandable member 170 to a desired shape and size. The desired shape andsize of the expandable member 170 may vary somewhat from patient topatient. Thus, a user using a unit dose may have excess light-sensitiveliquid left over. It is desirable to provide sufficient amount oflight-sensitive liquid to accommodate even the above-average patient. Inan embodiment, a unit dose of a light-sensitive liquid of the presentdisclosure is contained within a container. In an embodiment, a unitdose of a light-sensitive liquid of the present disclosure is containedin an ampoule. In an embodiment, the expandable member 170 issufficiently shaped and sized to fit within a space or a gap in afractured bone. In an embodiment, the light-sensitive liquid can bedelivered under low pressure via a standard syringe attached to theport.

As illustrated in FIG. 2 in conjunction with FIG. 3B, thelight-conducting fiber 140 can be introduced into the proximal end ofthe flexible delivery catheter 150 and passes within the inner lumen 154of the flexible delivery catheter 150 up into the expandable member 170.The light-conducting fiber 140 is used in accordance to communicateenergy in the form of light from the light source to the remotelocation. The light-sensitive liquid 165 remains a liquid monomer untilactivated by the light-conducting fiber 140 (cures on demand). Radiantenergy from the light source 110 is absorbed and converted to chemicalenergy to polymerize the monomer. The light-sensitive liquid 165, onceexposed to the correct frequency light and intensity, is converted intoa hard polymer, resulting in a rigid structure or photodynamic implantof the present disclosure. In an embodiment, the monomer 165 cures inabout five seconds to about five minutes. This cure affixes theexpandable member 170 in an expanded shape to form a photodynamicimplant of the present disclosure. A cure may refer to any chemical,physical, and/or mechanical transformation that allows a composition toprogress from a form (e.g., flowable form) that allows it to bedelivered through the inner void 152 in the flexible delivery catheter150, into a more permanent (e.g., cured) form for final use in vivo. Forexample, “curable” may refer to uncured light-sensitive liquid 165,having the potential to be cured in vivo (as by catalysis or theapplication of a suitable energy source), as well as to alight-sensitive liquid 165 in the process of curing (e.g., a compositionformed at the time of delivery by the concurrent mixing of a pluralityof composition components).

Light-conducting fibers use a construction of concentric layers foroptical and mechanical advantages. The light-conducting fiber can bemade from any material, such as glass, silicon, silica glass, quartz,sapphire, plastic, combinations of materials, or any other material, andmay have any diameter, as not all embodiments of the present disclosureare intended to be limited in this respect. In an embodiment, thelight-conducting fiber is made from a polymethyl methacrylate core witha transparent polymer cladding. The light-conducting fiber can have adiameter between approximately 0.75 mm and approximately 2.0 mm. In someembodiments, the light-conducting fiber can have a diameter of about0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mmor greater than about 2 mm as not all embodiments of the presentdisclosure are intended to be limited in this respect. In an embodiment,the light-conducting fiber is made from a polymethyl methacrylate corewith a transparent polymer cladding. It should be appreciated that theabove-described characteristics and properties of the light-conductingfibers are exemplary and not all embodiments of the present disclosureare intended to be limited in these respects. Light energy from avisible emitting light source can be transmitted by the light-conductingfiber. In an embodiment, visible light having a wavelength spectrum ofbetween about 380 nm to about 780 nm, between about 400 nm to about 600nm, between about 420 nm to about 500 nm, between about 430 nm to about440 nm, is used to cure the light-sensitive liquid.

The most basic function of a fiber is to guide light, i.e., to keeplight concentrated over longer propagation distances—despite the naturaltendency of light beams to diverge, and possibly even under conditionsof strong bending. In the simple case of a step-index fiber, thisguidance is achieved by creating a region with increased refractiveindex around the fiber axis, called the fiber core, which is surroundedby the cladding. The cladding may be protected with a polymer coating.Light is kept in the “core” of the light-conducting fiber by totalinternal reflection. Cladding keeps light traveling down the length ofthe fiber to a destination. In some instances, it is desirable toconduct electromagnetic waves along a single guide and extract lightalong a given length of the guide's distal end rather than only at theguide's terminating face.

In some embodiments, at least a portion of a length of anlight-conducting fiber is modified, e.g., by removing the cladding, inorder to alter the profile of light exuded from the light-conductingfiber. The term “profile of light” refers to, without limitation,direction, propagation, amount, intensity, angle of incidence,uniformity, distribution of light and combinations thereof. In anembodiment, the light-conducting fiber emits light radially in a uniformmanner, such as, for example, with uniform intensity, along a length ofthe light-conducting fiber in addition to or instead of emitting lightfrom its terminal end/tip. To that end, all or part of the claddingalong the length of the light-conducting fiber may be removed. It shouldbe noted that the term “removing cladding” includes taking away thecladding entirely to expose the light-conducting fiber as well asreducing the thickness of the cladding. In addition, the term “removingcladding” includes forming an opening, such as a cut, a notch, or ahole, through the cladding. In an embodiment, removing all or part ofthe cladding may alter the propagation of light along thelight-conducting fiber. In another embodiment, removing all or part ofthe cladding may alter the direction and angle of incidence of lightexuded from the light-conducting fiber.

In an embodiment, the cladding is removed by making a plurality of cutsin the cladding to expose the core of the light-conducting fiber. In anembodiment, the cladding is removed in a spiral fashion. In anembodiment, the cladding is removed in such a way that a similar amountof light is exuded along the length of the modified section of thelight-conducting fiber. In another embodiment, the cladding is removedin such a way that the amount of light exuded along the length of themodified section of the light-conducting fiber changes from the distalend to the proximal end of the modified section. In another embodiment,the cladding is removed in such a way that the amount of light exudedalong the modified section of the light-conducting fiber decreases fromthe distal end of the modified section of the light-conducting fibertoward the proximal end thereof. In an embodiment, to alter the profileof the light exuded from the modified section, the cuts in the claddingare located along the length of the fiber in a spiral. In an embodiment,the pitch or spacing between the cuts is varied along the length of themodified section of the light-conducting fiber. In an embodiment, thespacing between the cuts increases from the proximal end of the modifiedsection of the light-conducting fiber 165 to the distal end thereof suchthat the amount of light exuded from the modified section of thelight-conducting fiber progressively increases toward the distal end ofthe modified section of the light-conducting fiber.

In some embodiments, the light conducting fiber 140 is part of thedelivery catheter 150 or separately placed in the delivery catheter 150.In some embodiments, the light conducting fiber 140 is part of theexpandable member 170, or the light conducting fiber 140 is a separatecomponent that is placed in the expandable member 170 before or afterthe expandable member 170 is inserted into the cavity of the bone.

The expandable member 170 may be provided with a shape demanded by, forexample, the anatomy of the implantation site, characteristics of theload bearing member 115 or both. Suitable shapes include, but notlimited to, round, flat, cylindrical, dog bone, barbell, tapered, oval,conical, spherical, square, rectangular, toroidal and combinationsthereof. In an embodiment, the expandable member 170 is tubular or coneshaped having a substantially centerline opening extending for a lengthof the expandable member. In an embodiment, the external surface of theexpandable member 170 is resilient and puncture resistant. Theexpandable member 170 can be manufactured from a non-compliant(non-stretch/non-expansion) conformable material including, but notlimited to urethane, polyethylene terephthalate (PET), nylon elastomerand other similar polymers. In an embodiment, the expandable member 170is manufactured from a polyethylene terephthalate (PET). In anembodiment, the expandable member 170 is manufactured from a radiolucentmaterial, which permit x-rays to pass through the expandable member 170.In an embodiment, the expandable member 170 is manufactured from aradiolucent polyethylene terephthalate (PET). In an embodiment, theexpandable member 170 is manufactured from a conformable compliantmaterial that is limited in dimensional change by embedded fibers. In anembodiment, at least a portion of the external surface of the expandablemember 170 is substantially even and smooth.

In an embodiment, at least a portion of the external surface of theexpandable member 170 includes at least one textured element such as abump, a ridge, a rib, an indentation or any other shape. In anembodiment, at least a portion of the external surface of the expandablemember 170 protrudes out to form a textured element. In an embodiment,at least a portion of the external surface of the expandable member 170invaginates to form a textured element. In an embodiment, the texturedelement increases the friction and improves the grip and stability ofthe expandable member 170 after the expandable member 170 is insertedinto the fracture location. In an embodiment, the textured elementresults in increased interdigitation of bone-device interface ascompared to an expandable member without textured elements. In anembodiment, the textured element can be convex in shape. In anembodiment, the textured element can be concave in shape. In anembodiment, the textured element can be circumferential around the widthof the expandable member 170, either completely or partially.

In general, a bone graft or bone graft substitute can be used inconjunction with an expandable member 170 of the present disclosure. Inan embodiment, the bone graft is an allogeneic bone graft. In anembodiment, the bone graft is an autologous bone graft. In anembodiment, the bone graft substitute is a hydroxyapatite bonesubstitute. In an embodiment, a bone graft or bone graft substitute isused to fill in any gaps that may exist, for example, between theexternal surface of the expandable member 170 and the surfaces of thebone fragments. In an embodiment, a bone graft or bone graft substituteis used to fill any gaps that may exist, for example, between thetextured element of the expandable member 170 and the surfaces of thebone fragments.

In general, the expandable member 170 can include an external surfacethat may be coated with materials including, but not limited to, drugs(for example, antibiotics), proteins (for example, growth factors) orother natural or synthetic additives (for example, radiopaque orultrasonically active materials). For example, after a minimallyinvasive surgical procedure an infection may develop in a patient,requiring the patient to undergo antibiotic treatment. An antibioticdrug may be added to the external surface of the expandable member 170to prevent or combat a possible infection. Proteins, such as, forexample, bone morphogenic protein or other growth factors have beenshown to induce the formation of cartilage and bone. A growth factor maybe added to the external surface of the expandable member 170 to helpinduce the formation of new bone. Due to the lack of thermal egress ofthe light-sensitive liquid 165 in the expandable member 170, theeffectiveness and stability of the coating is maintained.

In an embodiment, the expandable member 170 is free of any valves. Onebenefit of having no valves is that the expandable member 170 may beexpanded or reduced in size as many times as necessary to assist in thefracture reduction and placement. Another benefit of the expandablemember 170 having no valves is the efficacy and safety of the system100. Since there is no communication passage of light-sensitive liquid165 to the body there cannot be any leakage of the light-sensitiveliquid 165 because all the light-sensitive liquid 165 is containedwithin the expandable member 170. In an embodiment, a permanent seal iscreated between the expandable member 170 and the delivery catheter 150that is both hardened and affixed prior to the delivery catheter 150being removed.

In an embodiment, abrasively treating the external surface of theexpandable member 170 for example, by chemical etching or air propelledabrasive media, improves the connection and adhesion between theexternal surface of the expandable member 170 and a bone surface. Thesurfacing significantly increases the amount of surface area that comesin contact with the bone which can result in a stronger grip.

The expandable member 170 can be infused with light-sensitive liquid 165and the light-sensitive liquid 165 can be cured to form a photodynamicsupport member 102, which can then be separated from the deliverycatheter 150.

In an embodiment, a separation area is located at the junction betweenthe distal end of the expandable member 170 and the delivery catheter150 to facilitate the release of the photodynamic support member 102from the delivery catheter 150. The separation area ensures that thereare no leaks of reinforcing material from the elongated shaft of thedelivery catheter and/or the photodynamic support member 102. Theseparation area seals the photodynamic support member 102 and removesthe elongated shaft of the delivery catheter by making a break at aknown or predetermined site (e.g., a separation area). The separationarea may be various lengths and up to about an inch long. The separationarea may also have a stress concentrator, such as a notch, groove,channel or similar structure that concentrates stress in the separationarea. The stress concentrator can also be an area of reduced radialcross section of cured light-sensitive liquid inside a contiguous crosssectional catheter to facilitate separation by the application oflongitudinal force. The stress concentrator is designed to ensure thatthe photodynamic support member 102 is separated from the deliverycatheter 150 at the separation area. When tension is applied to thedelivery catheter 150, the photodynamic support member 102 separatesfrom the shaft of the delivery catheter 150, substantially at thelocation of the stress concentrator. The tension creates a sufficientmechanical force to preferentially break the cured material and cathetercomposite and create a clean separation of the photodynamicimplant/shaft interface. It should of course be understood that thephotodynamic support member 102 may be separated from the deliverycatheter 150 by any other means known and used in the art, includingradial twisting, shear impact, and cross-sectional cutting.

In an embodiment, the shape of the photodynamic support member 102generally corresponds to the shape of the expandable member 170.Modification of light-sensitive liquid 165 infusion allows a user toadjust the span or thickness of the expandable member 170 to providespecific photodynamic support member 102 size and shape to each subject.In that the expandable member 170 is formable and shapeable by the userprior to the photocuring of the light-sensitive liquid 165 in theexpandable member 170, the photodynamic support member 102 best mirrorsthe size and shape of the area into which it is implanted. In anembodiment, the size and shape of the final photodynamic implantattempts to maximize the surface contact area with the surrounding bone,minimizing specific points of concentrated pressure. In an embodiment,the size and shape of the photodynamic support member 102 attempts tomaximize the surface contact area with the surrounding bone, minimizingspecific points of concentrated pressure.

FIG. 4A illustrates an embodiment of an articular photodynamic device ofthe present disclosure. The articular photodynamic device 400 includes aphotodynamic support member 402 and an articular member 404 attachable,either fixedly or removably, to the photodynamic support member portionand having a bearing surface 406. In an embodiment, the articular member404 attaches to the photodynamic support member 402 at the attachmentpart 414 of the articular member 404. Any known methods of attachmentknown in the art and suitable for attaching medical implants may beutilized. In an embodiment, the articular member 404 includes a recess408 configured to complementarily engage the photodynamic support member402. The recess 408 is shaped to correspond to the shape of thephotodynamic support member 402 so the photodynamic support member 402can be inserted into the recess 408. The photodynamic support member 402can be secured within the recess 408 with an adhesive, friction fit,threaded engagement, set screw or a pin, or any other known techniques.In an embodiment, the mechanism of attachment of the photodynamicsupport member 402 and the articular member 404 is such that, the angleof the articular member 404 relative to the central axis of thephotodynamic support member can be adjusted, as shown in FIG. 4B andFIG. 4C. In an embodiment, the articular member 404 is connected to thephotodynamic support member 402 at an angle, such as for repair of ahead of a humerus or femur. In an embodiment, the height of the implantcan also be adjusted by adjusting the depth of engagement between thephotodynamic support member 402 and the articular member 404, as shownin FIG. 4D and FIG. 4E.

In an embodiment, as shown in FIG. 4F, the photodynamic support member402 includes a centrator 412, while the articular member 404 includes acenterline recess 414 to assist centering the articular member 404 onthe photodynamic support member 402. Alternatively, as shown in FIG. 4G,the photodynamic support member 402 includes a centerline recess 416,while the articular member 404 includes a centrator 418.

FIG. 5A and FIG. 5B illustrates an embodiment of an articularphotodynamic device 500 that includes a photodynamic support member 502(which, in an embodiment, is made from an expandable member 170 filledwith an photodynamic liquid that has been cured in the expandable member170 to form a rigid structure as discussed above). The articularphotodynamic device 500 includes an articular member 504 having a shaft510. FIG. 5A shows the articular member 504 prior to insertion into thephotodynamic support member 502. The articular member 504 is attachable,either fixedly or removably, to the photodynamic support member portionand has a bearing surface 506. In an embodiment, the photodynamicsupport member 502 includes an opening 508 extending for a length of thephotodynamic support member 502 and is designed to receive a shaft 510of the articular member 504.

FIG. 5B shows an embodiment in which the articular member 502 isinserted into the opening 508 of the photodynamic support member 502. Insome embodiments, the opening 508 of the photodynamic support member 502is uniform throughout the length or the photodynamic support member 502is tapered. In an embodiment, the opening 502 tapers as the opening 508extends into the body of the photodynamic support member 502, as shownin FIGS. 5A and 5B. In an embodiment, the opening 508 is open on bothsides, i.e., a through-hole extending along the center of thephotodynamic support member 502. In an embodiment, the opening 508 isonly open on one side of the photodynamic support member 502. In anembodiment, the opening 508 is substantially centered. In an embodiment,the opening 508 can be created by inversion of one end of the balloon(or expandable member 170) toward the opposite end.

In an embodiment, similar to the photodynamic support member 502 shownin FIG. 5A and FIG. 5B, the expandable member 170, from which thephotodynamic support member 502 is formed, is tubular or cone shapedhaving a substantially centerline opening extending for a length of theexpandable member. The opening in the expandable member 170 can beuniform throughout the length or may be tapered. In an embodiment, theopening in the expandable member 170 is open on both sides or only openon one side. The delivery catheter 150 can connect to the expandablemember 170 either at the base 512 of the expandable member 170 or at oneor both legs 514 and 516 of the expandable member 170. In an embodiment,the expandable member 170 includes multiple inner lumens for passingmultiple light conducting fibers into each leg 514, 516 of thephotodynamic support member 502. Alternatively, the expandable member170 includes a single inner lumen that is spiral to allow the lightconducting fiber to wrap around the opening 508. In such an embodiment,the distal end of the light conducting fiber can be pre-shaped toprovide the distal end of the light conducting fiber with a spiralconfiguration.

The articular photodynamic device 500 also includes an articular member504 having a shaft 510 designed to be inserted into the opening 510 ofthe photodynamic support member 502. As the expandable member 170 isinfused with the light-sensitive liquid, the articular member 504 iscentered in the intramedullary cavity. Curing the light-sensitivematerial within the expandable member 170 forms the photodynamic supportmember 502, thereby anchoring the articular member 504 inside theintramedullary cavity and providing longitudinal and rotationalstability to the articular member 504. In an embodiment, the shaft 510of the articular member 504 is secured within the opening 508 in thephotodynamic support member 502 by friction fit, set screw, adhesives orany other means known in the art. In an embodiment, the surface of theopening 508 is textured to increase friction between the shaft of thearticular member and the photodynamic support member. In an embodiment,the articular member 504 of the articular photodynamic device 500 can beselected from existing joint replacement implants, including, but notlimited, to hip replacement implants, knee replacement implants, anklereplacement implants, wrist replacement implants, elbow replacementimplants, and shoulder replacement implants. Other joint replacementimplants include, for example, mandible, finger and toe implants.

In an embodiment, the photodynamic support member 502 may be formed witha plurality of expandable members 170, where each expandable member 170can be inflated or deflated independently of other expandable members170. The individual expandable members 170 can be inflated or deflatedas desired to adjust the position, angulation, alignment or combinationsthereof of the articular member 504.

In an embodiment, as shown in FIG. 6 , there is provided a photodynamicjoint repair device 600 that includes a first photodynamic bone repairdevice 602 having a first bearing surface 606 and a second photodynamicbone repair device 604 having a second bearing surface 608 complementaryto the first bearing surface 606. Each of the first and secondphotodynamic bone repair devices 602, 604 includes a photodynamicsupport member 610, 612 and an articular member 614, 616 having abearing surface 606, 608. The first surface 606 and the second surface608 are sufficiently designed to generally complement one another for anarticular engagement. In an embodiment, the first surface 606 and thesecond surface 608 include one or more corresponding protrusions andchannels such that the first surface 606 and the second surface 608articulate with respect to one another along a predetermined path. Inoperation, the first photodynamic bone repair device 602 is implantedinto one bone forming a joint in need of repair, while the secondphotodynamic bone 604 repair device is implanted into the other bone orbones of the joint. Once the first photodynamic bone repair device 602and the second photodynamic bone 604 are implanted into their respectivebones, the first bearing surface 606 is engaged with the second bearingsurface 608. Because the first bearing surface 606 and the secondbearing surface 608 are generally complementary to one another, thefirst bearing surface 606 and the second bearing surface 608 are able toarticulate with respect to one another to imitate natural motion of thejoint.

In reference to FIG. 7 , the articular photodynamic devices 100 can beused in conjunction with a complementary surface other than anotherphotodynamic bone repair device of the present disclosure, such as forexample, existing acetabular cups 702 and/or liners 704. Othercomplementary surfaces include a radial head, shoulder prosthesis, wristjoints, ankle joints, and mandible.

FIGS. 8A-8G illustrate an embodiment of method steps for repairing afractured or weakened articular head 802 of a bone 804 using anarticular photodynamic device of the present disclosure. An incision(not shown) is made through the skin of the patient's body to expose thebone 804. As shown in FIG. 8A, an access hole 806 is formed at the endof the bone 804 opposite the fractured or weakened articular head 802.The access hole 806 can be formed in the bone by drilling or othermethods known in the art. The access hole 806 is of any suitablediameter. In an embodiment, the access hole 806 has a diameter of about3 mm to about 10 mm. In an embodiment, the access hole 806 has adiameter of about 3 mm.

The access hole 806 extends through a hard compact outer layer of thebone 804 into the relatively porous inner or cancellous tissue of anintramedullary cavity 808. For bones with marrow, the medullary materialshould be cleared from the intramedullary cavity 808 prior to insertionof the inventive device. Marrow is found mainly in the flat bones suchas hip bone, breast bone, skull, ribs, vertebrae and shoulder blades,and in the cancellous material at the proximal ends of the bones likethe femur and humerus. Once the intramedullary cavity 808 is reached,the medullary material including air, blood, fluids, fat, marrow, tissueand bone debris should be removed to form a void or a hollowed out spacewithin the intramedullary cavity 808. There are many methods forremoving the medullary material that are known in the art and within thespirit and scope on the presently disclosed embodiments. Methodsinclude, for example, those described in U.S. Pat. No. 4,294,251entitled “Method of Suction Lavage,” U.S. Pat. No. 5,554,111 entitled“Bone Cleaning and Drying system,” U.S. Pat. No. 5,707,374 entitled“Apparatus for Preparing the Medullary Cavity,” U.S. Pat. No. 6,478,751entitled “Bone Marrow Aspiration Needle,” and U.S. Pat. No. 6,358,252entitled “Apparatus for Extracting Bone Marrow.”

The fractured or weakened articular head 802 (shown in FIG. 8A) is alsoexcised as shown in FIG. 8B.

Next, a guidewire may be introduced into the intramedullary cavity 808and positioned in the void in the intramedullary cavity 808. As shown inFIG. 8B, an expandable member 170 of an articular photodynamic device ofthe present disclosure can then be delivered over the guidewire into thevoid inside the intramedullary cavity 808. In this embodiment, thedelivery catheter 150 is connected to the expandable member 170 at theproximal end of the expandable member 170, that is, the end of theexpandable member facing the healthy end of the bone 804. In anembodiment, as shown in FIG. 8B, the expandable member 170 can extendfor a desired distance outside of the bone 804.

Once the expandable member 170 is in a desired position, the articularmember 104 is coupled to the expandable member 170, as shown in FIG. 8C,and placed in a desired position relative to the expandable member 170similar to the positions shown, for example, in FIGS. 4B-4E with respectto the articular member 404 relative to the photodynamic support member402 (which is formed from the expandable member 170). The articularmember 104 and the expandable member 170 are coupled together in anynumber of ways and combinations.

FIG. 8D, FIG. 8E, and FIG. 8F show examples of embodiments of thecoupling of the articular member 104 and the expandable member 170 in aradial bone. FIG. 8D shows an undercut 180 where the articular member140 is coupled to the expandable member 170. When the expandable member170 expands, the expandable member 170 cannot pull out once cured.

FIG. 8E shows the use of threads or barbs 190 inside the articularmember or the sleeve which engage the cured expandable member 170. FIG.8F shows a bone fixation device 192, such as an externally placed screwor cross-pin, through the coupling of the articular member 140 and thecured expandable member 140. Various other suitable mechanisms may beused to couple the articular member 140 to the expandable member 170.

As explained above, the light-sensitive liquid 165 can then be infusedthrough the inner void in the delivery catheter 150 into the expandablemember 170 to move the expandable member from a deflated state to aninflated state. In an embodiment, the expanded expandable member 170achieves a conformal fit with the intramedullary cavity 808. Inreference to FIG. 8C, in an embodiment, a distance D1 between thearticular member 104 and the end of the bone 804 can be adjusted byadjusting the length of the expandable member 170 in order to ensurethat a length D2 of the repaired bone 804 is substantially the same asthe native length of the bone 804.

Once the position of the articular member 104 and the fit of theexpandable member 170 within the intramedullary cavity 808 is confirmed,the light-sensitive liquid 165 may be hardened within the expandablemember 170, such as by illumination with a visible emitting light source(not shown), to form the photodynamic support member 102. After thelight-sensitive liquid has been hardened, the light source may beremoved from the device. Alternatively, the light source may remain inthe expandable member 170 to provide increased rigidity. Thephotodynamic support member 102 can then be released from the deliverycatheter 150 by any known methods in the art, thereby forming anarticular photodynamic device 100, as shown in FIG. 8G. In anembodiment, the photodynamic support member 102 achieves a conformal fitwith the intramedullary cavity 808 to provide longitudinal androtational stability to the articular photodynamic device 100.

It should be noted that, in an embodiment, the expandable member 170 canbe inserted into the intramedullary cavity 808 through the openingcreated by excising the fractured or weakened articular head 802. In anembodiment, in order to facilitate setting distance D1 between thearticular member 104 and the end of the bone 804, means for limiting thedepth of penetration of the expandable member 170 into theintramedullary cavity 808 can be implanted in the intramedullary cavity.In this manner, as the expandable member 170 is expanded in length dueto the addition of the light-sensitive liquid 165, the expandable member170 will be prevented from expanding into the intramedullary cavity, andinstead, will expand outside the intramedullary cavity 808. In addition,the articular member 104 may include an opening therethrough to pass thedelivery catheter.

FIG. 9A and FIG. 9B illustrate another embodiment of method steps forrepairing a fractured or weakened articular head 802 of a bone 804 inwhich an articular photodynamic device is inserted through the openingcreated in the bone by excising a fractured or weakened articular head802. In this embodiment, the delivery catheter 150 can be connected tothe expandable member 170 at the distal end of the expandable member170, as shown in FIG. 9A. Next, a shaft 902 of the articular member 104can be inserted into a centerline opening 904 in the expandable member170 to couple the articular member 104 to the expandable member 170.Next, the expandable member 170 can be infused with a light-sensitiveliquid 165. In FIG. 9A, the expandable member 170 has a U-shape with thecenterline opening 904. As the expandable member 170 moves from adeflated state to an inflated state, the shaft 902 of the articularmember 104 is centered relative to the central longitudinal axis of thebone 804. Thus, the articular member 104 fits within the centerlineopening 904 of the expandable member 170. Once the position of thearticular member 102 and the fit of the expandable member 170 within theintramedullary cavity 808 is confirmed, the light-sensitive liquid 165may be hardened within the expandable member 170 to form thephotodynamic support member 102, which can then be separated from thedelivery catheter 150. FIG. 9B shows the photodynamic support member 102separated from the delivery catheter 150 after the light-sensitiveliquid 165 has hardened within the expandable member 170.

FIG. 10A shows an embodiment in which an articular photodynamic device1000 can be used to replace a fractured or weakened proximal head (notshown) of a radius 1012. The fractured or weakened head of the radius1012 is excised and removed, and the photodynamic support member 1002(not shown) is formed inside the intramedullary cavity of the radius1012, as described above. In an embodiment, the photodynamic supportmember 1002 extends beyond the end of the radius 1012. In an embodiment,the photodynamic support member 1002 is located in the intramedullarycavity of the bone 1012 and extends from the shaft of the bone 1012through a sleeve 1003 and into the head of the bone 1012.

The articular photodynamic device 1000 also includes an articular member1004 engaging the photodynamic support member 1002 at the attachmentpart 1014 of the articular member 1004. The articular member 1004includes a bearing surface 1006. The articular member 1004 together withthe bearing surface 1006 are configured to approximate the dimensionsand size of the head of the radius 1012. In an embodiment, the articularmember 1004 has a cylindrical form and the bearing surface 1006 is inthe form of a shallow concavity or articular engagement with capitellumof the humerus 1015. The deepest point in the bearing surface 1006 isnot axi-symmetric with the long axis of the radius 1012, creating a cameffect during pronation and supination. In an embodiment, thecircumference of the articular member 1004 is smooth and the articularmember 1004 is broad medially where it articulates with the radial notchof the ulna 1016, narrow in the rest of its extent, which is embraced bythe annular ligament (not shown). The photodynamic support member 1002can be illuminated by a light conducting fiber.

As shown in FIG. 10A, in an embodiment, the photodynamic support member1002 includes a sleeve 1003 that covers the cured expandable member. Thesleeve 1003 is engaged with the expandable member by any suitable means.For example, the sleeve 1003 has a plurality of ridges on its innersurface to engage the expandable member and prevent the sleeve 1003 fromslipping off the expandable member. In an embodiment, the sleeve has anincreasing inner diameter to engage the expandable member and preventslippage. In an embodiment, the sleeve has an undercut in which theexpandable member enters to engage with the sleeve. The sleeve can becannulated. In FIG. 10A, the sleeve acts as the base of the radial headof the articular photodynamic device 1000. In an embodiment, the sleeveis an anchoring means. In another embodiment, the sleeve is a spacer.The sleeve is of any desired size.

FIG. 10B shows another embodiment of an articular photodynamic device1000 that can be used to repair or fixate a fractured or weakenedproximal head 1018 of a radius 1012. The fractured or weakened head 1018of the radius 1012 has not been excised in the embodiment shown in FIG.10B. The photodynamic support member 1002 is formed inside theintramedullary cavity of the radius 1012, as described above. In anembodiment, the photodynamic support member 1002 extends beyond the endof the shaft of the radius 1012. In FIG. 10B, an expandable member isused to join the fractured head of the bone with the shaft of the bone.The expandable member is inserted into the cavity of the bone and formedinto a photodynamic support member 1002 as described above. In FIG. 10B,a space exists between the head 1018 of the joint and the shaft of thebone 1012. In an embodiment, a sleeve is inserted into the space.

In an embodiment, the photodynamic support member 1002 brings the head1018 and shaft closer together to promote healing of the fractured orweakened bone. In an embodiment, a sleeve is inserted into the space. Inan embodiment, the photodynamic support member 1002 brings the head 1018and shaft into direct contact to promote healing of the fractured orweakened bone.

Although the articular photodynamic implant is described in connectionwith replacement of a head of a radius, the devices and methods of thepresent disclosure can also be used to replace a head of other bones,including, without limitation, the femurs, tibias, and fibulas of thelegs, the humeri and ulnas of the arms, metacarpals and metatarsals ofthe hands and feet, the phalanges of the fingers and toes, theclavicles, ankle, wrist, mandible, spinal articular surface bonesincluding, but not limited to, the facet joint and the vertebral body,ribs, temporomandibular joint, and pelvis.

In an embodiment, an articular photodynamic device of the presentdisclosure includes a photodynamic support member and an articularmember attachable, either fixedly or removably, to the photodynamicsupport member portion and having a bearing surface. In an embodiment,the articular member includes a recess designed to receive thephotodynamic support member. In an embodiment, the photodynamic supportmember includes an opening into which a shaft of the articular membercan be inserted to attach the articular member to the photodynamicsupport member.

In an embodiment, a photodynamic joint repair device of the presentdisclosure includes a first photodynamic bone repair device having afirst bearing surface and a second photodynamic bone repair devicehaving a second bearing surface complementary to the first bearingsurface, wherein each of the first and second photodynamic bone repairdevices include a photodynamic support member and a articular memberhaving a bearing surface.

In an embodiment, a device for restructuring or stabilizing a fracturedor weakened head of a bone includes a delivery catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, the delivery catheter having an inner void forpassing at least one light sensitive liquid, and an inner lumen; aexpandable member releasably engaging the distal end of the deliverycatheter, the expandable member moving from a deflated state to aninflated state when the at least one light sensitive liquid is passed tothe expandable member; wherein the expandable member is sufficientlydesigned to be at least partially placed into a space within a head of abone, and a light conducting fiber sized to pass through the inner lumenof the delivery catheter and into the expandable member, wherein, whenthe light conducting fiber is in the expandable member, the lightconducting fiber is able to disperse the light energy to initiatehardening of the at least one light sensitive liquid within theexpandable member to form a photodynamic implant.

In an embodiment, a method for repairing a fractured or weakenedarticular head of a bone includes removing the fractured or weakenedhead of the bone from the bone, placing a expandable member removablyattached to a distal end of a delivery catheter at least partially intoan intramedullary cavity of the bone, attaching an articular memberhaving a bearing surface to the expandable member, infusing a lightsensitive liquid into the expandable member through an inner lumen ofthe delivery catheter, inserting a light conducting fiber into theexpandable member through an inner void of the delivery catheter, andactivating the light conducting fiber to cure the light sensitive liquidinside the expandable member and separating the expandable member fromthe delivery catheter.

In an embodiment, a kit for repairing or stabilizing a fractured orweakened head of a bone includes an light conducting fiber, a unit doseof at least one light sensitive liquid, a delivery catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, wherein the delivery catheter has an inner void forpassing the at least one light sensitive liquid into a expandable memberreleasably engaging the distal end of the delivery catheter, and aninner lumen for passing the light conducting fiber into the expandablemember, and an articular member configured to engage the expandablemember and having a bearing surface. In an embodiment, the kit includesa plurality of expandable members of different sizes or shapes. In anembodiment, the kit includes a plurality of articular members havingdifferent sizes or shapes. In an embodiment, the kit includes a lightsource.

In one aspect, a device for replacement of an articular head of a boneincludes a support member and an articular member. The articular memberhas an articular part, a bearing surface disposed on the articular part,and an attachment part configured to complementarily engage the supportmember. The support member is sufficiently designed to reside within acavity of a bone to anchor the articular member inside the cavity.

In one aspect, a joint repair device includes: a first bone repairdevice having a first support member attached to a first articularmember having a first bearing surface; and a second bone repair devicehaving a second photodynamic support member attached to a secondarticular member having a second bearing surface complementary to andengaged with the first bearing surface.

In one aspect, a system for restructuring or stabilizing a fractured orweakened head of a bone includes: a delivery catheter having anelongated shaft with a proximal end, a distal end, and a longitudinalaxis therebetween, the delivery catheter having an inner void forpassing at least one light sensitive liquid therethrough, and an innerlumen; an expandable member releasably engaging the distal end of thedelivery catheter; an articular member attached to the expandable memberand having a bearing surface; and a light conducting fiber sized to passthrough the inner lumen of the delivery catheter and into the expandablemember. The expandable member is configured to receive the articularmember. The expandable member moves from a deflated state to an inflatedstate when the at least one light sensitive liquid is passed to theexpandable member. The expandable member is sufficiently designed to beat least partially placed into a space within the head of the bone. Whenthe light conducting fiber is in the expandable member, the lightconducting fiber is able to disperse light energy to initiate hardeningof the at least one light sensitive liquid within the expandable memberto form a photodynamic implant.

In an aspect, a method for repairing a fractured or weakened articularhead of a bone includes: removing the fractured or weakened head fromthe bone; placing an expandable member removably attached to a distalend of a delivery catheter at least partially into an intramedullarycavity of the bone; attaching an articular member having a bearingsurface to the expandable member, wherein the expandable member isconfigured to receive the expandable member; infusing a light sensitiveliquid into the expandable member through an inner lumen of the deliverycatheter; activating a light conducting fiber to cure the lightsensitive liquid inside the expandable member; and separating theexpandable member and the articular member from the delivery catheter.

In an aspect, a kit for repairing or stabilizing a fractured or weakenedhead of a bone includes: a light conducting fiber; at least one lightsensitive liquid; a delivery catheter having an elongated shaft with aproximal end, a distal end, and a longitudinal axis therebetween; anexpandable member releasably engaging the distal end of the deliverycatheter, wherein the delivery catheter has an inner void for passingthe at least one light sensitive liquid into the expandable member, andan inner lumen for passing the light conducting fiber into theexpandable member; and an articular member configured to be attached tothe expandable member and having a bearing surface.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that several of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or application. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art.

What is claimed is:
 1. A bone repair device comprising: an inflatable support member; and an articular member having an elongate shaft configured to attach to the inflatable support member, and a bearing surface; wherein the inflatable support member includes an elongate opening that is designed to receive the elongate shaft of the articular member, the inflatable support member being inflatable and deflatable to adjust at least one of a position, an angulation, and an alignment of the articular member relative to the inflatable support member when the elongate shaft is positioned within the elongate opening of the inflatable support member.
 2. The bone repair device of claim 1, wherein the articular member is fixedly attached to the inflatable support member.
 3. The bone repair device of claim 1, wherein the articular member is removably attached to the inflatable support member.
 4. The bone repair device of claim 1, wherein the bearing surface is configured to enter into an articular engagement with an articular head of a bone opposing the bone to be repaired.
 5. The bone repair device of claim 1, wherein the articular member is configured to approximate dimensions and size of an articular head of a bone being repaired using the bone repair device.
 6. The bone repair device of claim 1, wherein the inflatable support member is configured to reside within a cavity of a bone to anchor the articular member inside the cavity.
 7. The bone repair device of claim 1, further comprising a second inflatable support member and a second articular member configured to be used in conjunction with the inflatable support member and the articular member.
 8. The bone repair device of claim 7, wherein the inflatable support member and the second inflatable support member are configured to be positioned in a space within bone.
 9. The bone repair device of claim 7, wherein the bearing surface of the articular member is configured to engage with a bearing surface of the second articular member.
 10. A bone repair device comprising: an inflatable support member; and an articular member having a recess configured to attach to the inflatable support member, the recess having a shape that corresponds to a shape of an end of the inflatable support member, and a bearing surface; wherein attachment of the inflatable support member and the articular member allows for adjustment of an angle of the articular member relative to the inflatable support member, and wherein the inflatable support member being inflatable and deflatable to adjust at least one of a position, an angulation, and an alignment of the articular member relative to the inflatable support member when the articular member is attached to inflatable support member.
 11. The bone repair device of claim 10, wherein the articular member is fixedly attached to the inflatable support member.
 12. The bone repair device of claim 10, wherein the articular member is removably attached to the inflatable support member.
 13. The bone repair device of claim 10, wherein the articular member is adjusted relative to a central axis of the inflatable support member.
 14. The bone repair device of claim 10, wherein a height of the bone repair device is configured to be adjusted by adjusting a depth of engagement between the inflatable support member and the articular member.
 15. The bone repair device of claim 10, further comprising a second inflatable support member and a second articular member configured to be used in conjunction with the inflatable support member and the articular member.
 16. The bone repair device of claim 10, wherein the inflatable support member is configured to reside within a cavity of a bone to anchor the articular member inside the cavity. 